ISO 13485:2016

TOPIC’s Quality Management System (QMS) adheres to the ISO 13485:2016 standard. This standard contains the conditions our QMS must meet to be allowed to develop medical products. The use of this QMS also allows us to develop other (non-medical) products for you. Important aspects we pay attention to within this standard are:

  • Risk management
  • Quality management
  • Requirements management & traceability
  • Validation & Verification
  • Documentation